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Creating a Latex-Safe Environment

Apr 30, 2000

More often than not, hospitals are beginning to recognize latex allergy as a serious concern that affects both patients and healthcare workers (HCWs) alike. But what exactly is latex allergy? Latex allergy may be a Type 1 IgE-mediated hypersensitivity reaction that comes from a systemic antibody formation as a reaction to proteins in products made from natural rubber latex. There are two types of latex allergy. Type I is a sensitivity or allergic clinical reactivity to the protein allergens. Type IV is a sensitivity or allergic clinical reactivity to the chemicals used in the manufacturing process. Most individuals diagnosed as latex allergic are "sensitive" or allergic to the chemicals and not necessarily to the protein allergens.

However, most see latex allergy as an acquired allergy that exhibits in response to latex protein. Therefore, in a hospital setting where so many products are either made from latex rubber (such as surgical or exam gloves) or have trace latex components, the exposure effect should show up as allergic reactions. It would seem that HCWs would suffer a higher incidence of latex sensitivity than in other occupations, since exposure to products containing latex is so prevalent in all types of medical devices: surgical masks, catheters, injection ports, tourniquets, stethoscopes, blood pressure cuffs, surgical tapes, and gloves.

Between 1988 and 1994, 40,000 randomly selected subjects were surveyed and examined at 88 locations nationwide in a survey conducted by the National Center for Health Statistics called the NHANES III. This survey is conducted periodically to gather representative data on the health and nutritional status of the US population. Over 30 topics were investigated in the NHANES III including HIV, hepatitis, immunizations, diabetes, high blood pressure, obesity, and allergies among others. More than 5,500 adults in the study were tested for sensitivity to latex, the most comprehensive study of this type. The Diagnostic Product Corporation's (Los Angeles, Calif) AlaSTAT® test was used in the study to determine latex sensitivity. This test measures the level of natural rubber latex IgE antibodies in blood serum samples. When exposed to enough allergens, some people are atopic--genetically predisposed to create antibodies to rubber. A 0.35 IU/mL is the positive significant level for a person to be determined to be sensitive to latex, though he/she may never have an actual allergic reaction.

Results of the survey, reported in 1997, showed that one in five persons in the US is likely to be sensitive to natural rubber regardless of their occupation. Of those tested, 23 occupations have lower rates than HCWs who wear gloves and 15 have higher rates. Those in the highest ranges include writers (29.1%), mechanics (28.3%), farmers (25.5%), food workers (22.6%), and construction workers (20.5%). Analyses indicate that occupation is not a significant factor when associated with latex sensitivity in this survey. When asked if they had or still have asthma, both HCWs using gloves and all others questioned answered "yes" at the same rate (2.8%) in this study.

Though there is no connection between occupation and sensitivity to natural rubber, those who tend to exhibit multiple allergies (bananas, kiwi, guava, potatoes, tomatoes, chestnuts, bee stings, and pollen) tend to be prone to latex sensitivity as well. According to a poster presentation at AORN (April 2000) presented by the Southwest Illinois Chapter 1410, approximately 6%--18 million Americans--tend to exhibit signs of latex allergy. Those who exhibit higher than normal reactivity include 51% of children with spina bifida, those with genitourinary problems (especially people requiring frequent catheterization), people with sensitivity to latex balloon tip during barium enema procedures, and those with multiple surgical procedures.

How Does Latex Allergy Affect HCWs and Patients?

A positive sensitivity test may not result in latex allergic reactivity. However, latex allergy reactions can be identified by many common responses such as:

Usually in sensitized persons, symptoms begin shortly after exposure. However, they can occur hours later. The milder reactions are those of skin redness, rash, itching, or hives. More serious reactions involve sneezing, itchy eyes, scratchy throat, and asthma. The most serious type of life-threatening reaction wherein a patient or HCW shows signs of shock is seldom the first sign of latex allergy.

As in most situations, the best response to latex allergy is to be prepared for any eventuality. There is no known cure for latex allergy. Therefore, providing latex-free gloves for people sensitive to latex is a practical approach. Simply asking new hires or new patients latex allergy questions is an easy prevention step. Washing hands to remove glove powder helps. Because planning for the latex-allergic patient involves many departments and services that provide care and because latex allergy may affect a broad spectrum of employees, setting up a committee to manage the latex allergy is helpful. Heightened awareness augments assessment skills, which may lead to the identification of patients/HCWs with undocumented latex sensitivity and allergy.

For employees exhibiting signs of allergic-type reactions, healthcare facilities may provide the skin prick test, the AlaSTAT assay or another type of test, such as the RAST or ELISA, for identification of anit-latex IgE. This type of testing may confirm the presence of IgE antibodies, therefore, confirming a latex sensitivity. Serum and skin prick testing confirms sensitivity and may not necessarily confirm allergy because the possibility always exists that the allergic reaction may be due to the "chemicals." As many as half of US hospitals have adopted a committee approach for assessing, managing, educating, and avoiding allergic responses to natural rubber, and testing suspected HCWs is the first step.

If one in five persons in the US are sensitive to natural rubber latex, and of those who are sensitive, some responses will show allergic symptoms, then the practical approach is to be prepared. There's no known cure for latex allergy. Avoidance of latex, especially by providing latex-free gloves provides some protection. Simply asking latex allergy questions of new hires and patient admissions helps identify the problem. Testing high-risk employees may confirm the condition. Washing hands to remove glove powder after wearing gloves also helps. Thoroughly cleaning surfaces between patients helps. Avoiding latex in products other than gloves helps. Having an allergist/immunologist on the latex allergy committee can provide valuable information as to treatment for any eventuality.

Manufacturers Respond to the Latex-Free Needs

According to Diane Sosovec, RN, MS, CNAA, the manager of clinical resources for Allegiance Healthcare Corporation (McGaw Park, Ill), there are an estimated 40,000 products that contain natural rubber latex. Many of these are used in the hospital setting. Allegiance offers hospitals a variety of latex-free products, even down to the stretch bands on bouffant caps and shoe covers which went latex-free back in 1993. To check what products contain natural latex rubber, Sosovec suggests reading the label carefully since as of October 1, 1998, the FDA has mandated that all medical products/devices containing natural rubber must be labeled as such with a specific warning.

One of the most useful methods that Allegiance has taken is to provide latex-free procedure modules (PBDS). Within the PBDS product line there are standard modules providing latex-free products for six different procedures: general surgery, neurosurgery, pediatric, C-section, vaginal delivery, and orthopedic surgery as well as an anesthesia kit. All modules include kits for IV start, patient prep, anesthesia, clean-up, PACU, and sterile surgical packs.

"We took the hassle out of the hospital's search for latex-free products. All six of our modules are bundled products for a certain procedure that are latex-free, making it easy for hospitals," comments Heidi Polcek, Marketing Manager for PBDS.

All six of the latex-free modules contain most of the products needed for that specific procedure, making it easy for hospitals to have the latex-free components they need to provide care for their patients. These standard modules were designed by Allegiance's Clinical Project Managers. PBDS has researched and confirmed that all the products in their modules are latex-free. They also manufacture the modules in a special latex-free environment to ensure no contamination during the assembly process.

In providing latex-free choices in gloves, Allegiance takes a practical approach. When choosing a glove, the first consideration should be the barrier needed that relates to the task at hand. Once the level of exposure risk is determined, the match between the appropriate glove can be made. Any patient-care activities that involve blood, body fluids, and other potentially infectious material and any activities involving exposure to sharps are considered high risk. Activities that require minimal exposure to blood or body fluids are considered low risk, such as handling food, emptying a urinal, or suctioning.

Selecting the appropriate type of glove for the task, when providing latex-free materials, is key. For instance, vinyl examination gloves are appropriate for short-term risk involving minimal stress and exposure. Vinyl exam gloves need to be changed every 15 minutes according to the company's literature. Nitrile rubbers--polymers of butadiene, acrylonitrile, and carboxlyic acid--can be used for tasks with prolonged exposure to blood and body fluids, cleaning solutions, chemotherapeutic agents, and other chemicals. For maximum barrier protection, it is recommended that nitrile gloves be changed every 15 to 30 minutes. Allegiance's glove in this area is called the Flexam® Nitrile Ambi Examination Glove. Neoprene and copolymers of chloroprene is a synthetic rubber with inherent high tensile strength, elongation, and wear features. Surgical gloves made of neoprene are indicated for tasks requiring a sterile hand covering with fit, feel, and manual dexterity. This type of glove should be changed every one to three hours. Allegiance Duraprene Synthetic Surgical Glove provides the alternative choice for the latex material in this category. This glove is available both in powdered and powder-free varieties and is made using a patented synthetic formulation that emulates natural rubber latex.

David Watermeier, product director for Unitized Delivery Systems offered by DeRoyal (Powell, Tenn) also has a Latex Safe Standard TracePak. With the Latex Safe TracePak, each kit is configured for a specific procedure and is delivered in a portable, easily stored container. Standardized procedure carts are available for vaginal delivery, C-Section, general surgery, orthopedic, or laparoscopy. If needed, the company will customize a hospital's TracePak of surgical supplies so that supplies needed for each stage of the procedure are packaged together in a series of bundles, delivered just-in-time, and all products are latex-free. Other available latex-safe kits include: IV start kits, anesthesia kits, patient positioning kits, prep kits, basin sets, surgical accessory kits, wound dressing kits, and procedural trays.

"Manufacturers have responded so quickly to the latex issue that it's now much safer than it was in the past," says Watermeier. "Though the number of people who are latex sensitive is growing, the problem is shrinking because manufacturers have been creating so many latex-safe products so quickly."

This seems to be an accurate assessment of the situation. Medline Industries, Inc. (Mundelein, Ill) announced a latex-free cart system to deliver a complete supply of latex-free products to one easy location recently. The cart contains a wide array of latex-free products to treat patients or HCWs who are latex sensitive including endotracheal tubes, gloves, IV start kits, syringes, nursing supplies, PPE, resuscitatiors, suction products, and wound care products.

Patricia Johns at Arrow International says, "We clearly label our products latex-free. We're working to make 1700 of our products latex free. Many of our radial artery catheters are latex-free products. In some products, such as balloon thermodillution-types of catheters it's hard to get rid of latex. This is because a latex balloon has better performance issues than polyurethane balloons. But we are removing the latex from our O rings, latex bands, glues, and from other catheters."

At the AORN conference (April 2000), Maxxim Medical (Clearwater, Fla) announced its powder-free, latex-free surgical glove made with Isolex, a polyisoprene synthetic polymer. Gynecare, a division of Ethicon, Inc, a Johnson & Johnson company announced an alternative to hysterectomy or other surgical procedures by using the Thermachoice Uterine Balloon Therapy to treat excessive bleeding. The procedure destroys the uterine lining by using heat. The balloon, made of a silicone material, eliminates the risk to latex-sensitive women. In the same time period, Tri-State Hospital Supply Corporation, manufacturers of Centurion® hospital products announced Latex-Free Products and Procedure Kits. Items such as gloves, face masks, gowns, IV infusion sets, dressings, tourniquets, tapes, and more are all available using non-sensitizing materials. Latex-free procedure kits include dressing changes, IV starts, port access, and others.

Conclusion

What irony that the gold standard in bloodborne pathogen barrier protection, the latex glove, has become the source for concern in the issue of latex sensitivity. Though the number of employees and patients who exhibit latex allergy symptoms is not large in size, the problem remains an important one. Managing the problem can become easier with the cooperation of a hospital-wide committee addressing the issue and with the help of manufacturers/suppliers who have adapted to the issue quickly.

For more information, contact government and manufacturer/supplier websites. The following sources provide latex sensitivity information: